announced on 1 July 2020 to adopt 48 group standards developed by the Chinese Crop Protection Industry Association, which can be voluntarily adopted by applicants/registrants during the new submission, renewal and amendment of pesticide registration.
As a major element of the new data requirements, the applicant needs to put forward the quality-relevant indicators in the product specification, the testing methods, method validation data, explanation on the development the specification and complete corresponding quality tests. Once the indicators were deemed reasonable and the test results were coincident with the indicators, the data review may proceed to the next stage.
The selection of the quality parameters and the establishment of the quality control index could be complicated due to the variable combination of active ingredients and formulation type, availability of recognized method, the stability of production process and validation process, as well as the limited number of testing institutions qualified for the tests and validation.
To help facilitating the pesticide registration process and exportation, CCPIA has continuously developed various pesticide quality standards for specific ais and formulations. After being recognized by MoARA, manufacturers of the standardized products may save a lot of effort in determining and validating the parameters by providing following data:
- Full text of the CCPIA quality standard;
- Validation data for developing the standard;
- thermal stability data and quality tests based on 5 batches of products.
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